NCT05652296

External Ventricular Drainage Post-Market Clinical Follow-up Registry

Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.

Detailed description

The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations. Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.

Conditions

• Cerebrospinal; Disorder

Interventions

Type	Name	Description
DEVICE	External Ventricular Drainage (EVD)	EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain

Timeline

• Start date: 2023-03-03
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2022-12-15
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

4 sites across 2 countries: Belgium, France